Flint 1989.
Methods |
Study design: RCT, Zelen design. Duration of study: 1983‐1985. |
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Participants | Setting: tertiary hospital and community settings, St George's Hospital, London, UK. Inclusion criteria: low risk of complications who booked at the study hospital and were likely to receive all their antenatal care at that hospital. Exclusion criteria: under 5 feet tall, serious medical problems, previous uterine surgery, past obstetric history of > 2 miscarriages/TOP/SB/NND, Rh antibodies. Participants randomised: 503 team‐midwifery, 498 to standard care (shared care). | |
Interventions | Experimental: team of 4 midwives who provided antenatal, intrapartum and postnatal care in hospital, and postnatal care in the community for women in predefined geographic area. Obstetrician seen at 36 and 41 weeks as appropriate. Control: standard antenatal, intrapartum and postpartum care provided by assortment of midwives and obstetricians. | |
Outcomes | Outcomes considered in the review and reported in or extracted from the study: 5‐minute Apgar score below or equal to 7 Admission to special care nursery/NICU Amniotomy Antenatal hospitalisation Augmentation/artificial oxytocin during labour Caesarean birth Episiotomy Fetal loss/neonatal death before 24 weeks Fetal loss/neonatal death equal to/after 24 weeks High perceptions of control during labour and childbirth Induction of labour Intact perineum Instrumental vaginal birth (forceps/vacuum) Low birthweight (< 2500 g) No intrapartum analgesia/anaesthesia Opiate analgesia Fetal loss and neonatal death PPH (as defined by trial authors) Regional analgesia (epidural/spinal) Spontaneous vaginal birth (as defined by trial authors) |
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Notes | At baseline, more Asian women in control group (18% vs 10%) and more smokers in experimental group (30% vs 22%). Sub‐analysis of case notes found that 98% of experimental group and 20% of standard group had previously met midwife attending labour. Discrepancy in instrumental birth data. Date taken from report and not published paper. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated. |
Allocation concealment (selection bias) | Unclear risk | '...randomised into two groups by pinning sealed envelopes on their notes containing either the motto KNOW YOUR MIDWIFE or CONTROL GROUP' (Does not state if envelopes were number consecutively.). |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated but unlikely. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated but unlikely. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up = 15 team care, 19 standard care. |
Selective reporting (reporting bias) | Low risk | Outcome reporting: all outcomes stated in the methods section were adequately reported in results. |
Other bias | Low risk | No other bias identified. |